amyotrophic lateral sclerosis
Conditions
Interventions
Group A:phase I: primidone 60 mg/d
Wash-out period: no intervention
phase II: placebo control
Group B:phase I: placebo control
phase II: primidone 60 mg/d
Sponsors
The First People's Hospital of Yichang
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Clinically positive, probable and probable ALS in accordance with the 1998 revised IEEscorial standards; 3. Medulla oblongata dysfunction (determined by the principal investigator through an interview); 4. CNS-BFS score range is 50-90 points; 5. Subjects who can take or receive oral medication; 6. Informed consent has been signed; 7. If patients are taking riluzole, they must have taken it at least 30 days before randomization; 8. Patients taking salivation medications, such as Nuedexta (DMQ), dextromethorphan, and quinidine, must have stopped taking them within 30 days prior to enrollment to be eligible for inclusion in the study.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical studies within 3 months; 2. Tracheal intubation or invasive assisted ventilation; 3. Pregnant and lactating women; 4. Patients allergic to permidone; 5. ALT or AST is more than 3 times of the normal value; 6. Creatinine clearance rate < 50 ml/min; 7. Diseases or injuries that interfere with functional assessment or endanger life; 8. Any known motor neurone disease not associated with ALS; 9. Major mental illness, cognitive impairment; 10. Have irregular medication history in the past 3 years (patients with poor compliance with regular medication); 11. Patients with visual changes, diplopia, nystagmus and ataxia; 12. Those suffering from porphyria; 13. Suffering from asthma, chronic obstructive pulmonary disease or other respiratory conditions that may aggravate breathing difficulties or airway obstruction; 14. Patients with coagulation dysfunction; 15. Patients with impaired liver and kidney function; Proteinuria ++ and above; 16. Systolic blood pressure of less than 90 mmHg or diastolic pressure of 50 mmHg and heart rate of less than 50 beats per minute; 17. Unwilling or unable to participate in and complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of Center for Neurologic Study Bulbar Function Scale (CNS-BFS) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-rating dysphagia Scale;sub-water test;The Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40);Serum interleukin-8 leve; | — |
Countries
China
Contacts
Public ContactYunhong Zha
The First People's Hospital of Yichang
Outcome results
None listed